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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Safety Assessment of Alkyl Benzoates as Used in Cosmetics
Author:
Becker LC, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler D, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Andersen FA.
Year:
2012
Bibliographic source:
International Journal of Toxicology, November/December 2012 vol. 31 no. 6 suppl 342S-372S

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin irritation study was conducted on the clipped dorsum and external surface of the outer ear of male new Zealand albino rabbits to assess the skin irritation potential of test chemical Methylbenzoate (CAS No: 93-58-3)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Methylbenzoate
- Molecular formula: C8H8O2
- Molecular weight: 136.149 g/mol
- Substance type: Organic
- Physical state: Liquid
-Smiles : COC(=O)c1ccccc1
- InChI: 1S/C8H8O2/c1-10-8(9)7-5-3-2-4-6-7/h2-6H,1H3
Specific details on test material used for the study:
- Name of test material (as cited in study report): Methylbenzoate
- Molecular formula: C8H8O2
- Molecular weight: 136.149 g/mol
- Substance type: Organic
- Physical state: Liquid
-Smiles : COC(=O)c1ccccc1
- InChI: 1S/C8H8O2/c1-10-8(9)7-5-3-2-4-6-7/h2-6H,1H3

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No data available

Test system

Type of coverage:
not specified
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Amount :0.5ml on clipped dorsum and 0.2ml on external surface of the outer ear
concentration applied: 100%
Duration of treatment / exposure:
6 days

Observation period:
6 days
Number of animals:
14
Details on study design:
- Area of exposure: dorsum and external surface of the outer ear

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 6 d
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
rated as Grade 1
Irritant / corrosive response data:
On the dorsum there were marked cellular reactions and dermal edema beginning on day 2 followed by dermal hemorrhage, desquamated crust, and thickening of the malpighian stratum beginning on day 5. On the inner ear, there was slight hyperkeratosis on day 6.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Methylbenzoate (CAS No: 93-58-3) was considered to be irritating to the clipped dorsum and external surface of the outer ear of male new Zealand albino rabbits as it was rated grade 1.
Executive summary:

Skin irritation study of test chemical Methylbenzoate (CAS No: 93-58-3)was carried out in 14male New Zealand albino rabbitsto observe its irritation potential.

Undiluted methyl benzoate was applied to the clipped dorsum (0.5mL) and external surface of the outer ear (0.2mL)of 14 male New Zealand albino rabbits The rabbits were observed for 6 days for signs of irritation.On the dorsum there were marked cellular reactions and dermal edema beginning on day 2 followed by dermal hemorrhage, desquamated crust, and thickening of the malpighian stratum beginning on day 5 were observed and on the inner ear, there was slight hyperkeratosis on day 6.

Since the test chemical was rated as grade 1,Methylbenzoate (CAS No: 93-58-3) was considered to be irritating to the clipped dorsum and external surface of the outer ear of male new Zealand albino rabbits.